FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GelPOINT V-Path Vaginal Access System
K Number: K220969
·
Decision Sep 16, 2022
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
1
Applicant Total
12
Review Days
165
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Basic Information
- Device Name
- GelPOINT V-Path Vaginal Access System
- K Number
- K220969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1630
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Medical Resources Corporation
- Date Received
- April 4, 2022
- Decision Date
- September 16, 2022
- Product Code
- MOK
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOK | Vaginoscope And Accessories | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOK), ordered by most recent decision date.
View allOther Clearances by Applied Medical Resources Corporation
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